Physical Activity Intervention for Gestational Diabetes

NCT03664089 | Completed

• 1 other identifier: 18-00178
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Gestational diabetes mellitus (GDM) portends an immediate, increased risk for Type 2 diabetes mellitus (T2DM). The increased risk associated with having GDM is compounded by excess weight retention. Therefore, the weeks and months immediately after a GDM-complicated pregnancy present an optimal window to initiate lifestyle changes to prevent or delay T2DM. The long-term goal is to prevent T2DM among women with GDM. This study's objective is to evaluate the efficacy of a novel, yet simple, activity-boosting intervention on weight loss among women with GDM.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Weight loss

  Postpartum weight loss will be defined as weight change from initial weigh-in at NCH Visit 1 to final weigh-in at NCH Visit 2. Weight will be measured in person using the Tanita.

  NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

Secondary Outcomes (10)

• Body Fat %

  NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

• BMI

  NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

• Waist-hip Ratio

  NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

• Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: Oral Glucose Tolerance Test (OGTT)

  NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

• Glycemia and Associated Biomarkers of Insulin Resistance and Metabolic Health: HOMA

  NCH Visit 1 (25-35 days postpartum) to NCH Visit 2 (220-240 days postpartum)

Study Arms (2)

Intervention

EXPERIMENTAL

Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds \[1.1 kg\]/ankle), instructions on ankle weight usage (wear during normal activity for 2 hours/day, 7 days/week). The weight type and weight amount were chosen based on previously published literature and used in our preliminary work.

Behavioral: Ankle weights (2.5 pounds [1.1 kg]/ankle)

Control

PLACEBO COMPARATOR

All women in the control group will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

Behavioral: Control

Interventions

Ankle weights (2.5 pounds [1.1 kg]/ankle) BEHAVIORAL

Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds \[1.1 kg\]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.

Intervention

Control BEHAVIORAL

Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: We are assessing postpartum weight loss, therefore participants must be female to have the ability to give birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+ years
• Diagnosed with GDM in current pregnancy
• English language ability adequate for participation
• Plan to remain in the area for study duration
• Ability to provide informed consent

You may not qualify if:

• Prior Type 1 or Type 2 diabetes
• Pregnant with multiples (e.g., twin, triplets, etc.)
• Premature infant \[\<35 completed weeks gestation (assessed after delivery, before randomization)\]
• Heart disease, serious illness, or conditions that may impede or prohibit participation in either study arm
• Pre-pregnancy BMI \<18.5 (underweight)
• Live outside 35 mile radius of Ohio State University
• Woman is an appointed surrogate
• Infant will be adopted after delivery

Sponsors & Collaborators

• Sarah Keim: lead
• Ohio Department of Health: collaborator
• Ohio State University: collaborator
• American Diabetes Association: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

• Racke CA, Keim SA, Yisahak SF, Stith BJ, Thung SF, Klebanoff MA, Gabbe SG, Landon MB, Oza-Frank R. Postpartum Physical Activity Intervention Among Women With Gestational Diabetes: A Randomized Controlled Trial. Am J Lifestyle Med. 2025 Jun 14:15598276251351809. doi: 10.1177/15598276251351809. Online ahead of print.

  PMID: 40535905 DERIVED

• Stith BJ, Buls SM, Keim SA, Thung SF, Klebanoff MA, Landon MB, Gabbe SG, Gandhi KK, Oza-Frank R. Moms in motion: weight loss intervention for postpartum mothers after gestational diabetes: a randomized controlled trial. BMC Pregnancy Childbirth. 2021 Jun 29;21(1):461. doi: 10.1186/s12884-021-03886-3.

  PMID: 34187391 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sarah Keim, PhD, MA, MS

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: September 10, 2018
• Study Start: September 10, 2018
• Primary Completion: February 22, 2022
• Study Completion: July 1, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)